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About 854 results for "ema"

PRAC: Hep B Reactivation Risk With Direct-Acting Antivirals

The European Medicines Agency's (EMA's) Pharmacovigilance Risk Assessment Committee (PRAC) has confirmed the risk for hepatitis B virus (HBV) reactivation when direct-acting antiviral drugs are used for treatment of hepatitis C virus (HCV) ... Diabetes Care, 22 hours ago

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prweb.com, 4 days ago
Architect's Newspaper, 3 days ago

EMA Begins Review of Select Injectable Allergy Medications

Due to system maintenance, our Medscape site is temporarily unavailable (this includes access to Physician Connect, Medscape Mail, and our CME activities). We expect this maintenance period to last a few hours. We apologize for the inconvenience. ...
 General Medicine eJournal21 hours ago

Glaxo files marketing application in Europe for inhaled triple combo COPD therapy

GlaxoSmithKline (NYSE: GSK ) submits a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) seeking approval of a once-daily, closed triple combination therapy fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI ...
 Seeking Alpha1 day ago GSK submits MAA to EMA seeking approval for shingles vaccine, Shingrix  PharmaBiz5 days ago BRIEF-GlaxoSmithKline submits marketing application for shingles vaccine to EMA  Reuters UK1 week ago GSK Announces EU Regulatory Submission of Candidate Vaccine for Prevention of Shingles  CPhI.cn3 days ago

Simpler website navigation for regulatory information on human medicines

01/12/2016 New navigation to help users find information more easily The European Medicines Agency (EMA) has simplified the navigation structure of the regulatory information on human medicines on its website, to help users from pharmaceutical ...
 European Medicines Agency1 day ago
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Reuters India

British band Duran Duran lose battle to reclaim U.S. rights

British band Duran Duran talk on the stage after receiving the "Video Visionary" award during the MTV EMA awards at the Assago forum in Milan, Italy, October 25, 2015. REUTERS/Stefano Rellandini/FilesMore LONDON (Reuters) - The British 1980s pop ...
 Yahoo! Finance1 day ago Duran Duran lose battle to reclaim U.S. rights  Reuters UK1 day ago
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Coherus Bio's marketing application for Neulasta biosimilar accepted for review

The European Medicines Agency (EMA) accepts for review Coherus BioSciences' (NASDAQ: CHRS ) Marketing Authorization Application (MAA) seeking approval of CHS-1701, a biosimilar to Amgen's (NASDAQ: AMGN ) Neulasta (pegfilgrastim). This is the first ...
 Seeking Alpha2 days ago Coherus Announces Marketing Authorization Application to the EMA for Pegfilgrastim Biosimilar  JD Supra2 days ago BRIEF-Coherus says EMA accepts marketing authorization application for CHS-1701  Reuters UK4 days ago Coherus Marketing Authorization Application to European Medicines Agency for CHS-1701 (Pegfilgrastim Biosimilar Candidate) Accepted  SPi World News4 days ago
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European Medicines Agency

Analysis: EMA studies applications for central nervous system disorder medicines

An analysis of over 100 applications submitted between 1995 and 2014 to the EMA shows that various challenges can arise in the development of medicines meant to treat central nervous system (CNS) disorders, and highlights the importance of an ...
 Center Watch1 day ago Development challenges for medicines for central nervous system disorders  European Medicines Agency4 days ago

New vacancy: Temporary Agent (AD6), Project manager

Job profile for EMA/AD/400: Project manager, Information Management Division, IT Delivery Department, Project Management Service (AD6) (English only) 2016-11-30 Application form for EMA/AD/400: Project manager, Information Management Division, ...
 European Medicines Agency3 days ago
Reuters

Joint GMP inspections by EMA and FDA discussed as part of TTIP

The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) could be carrying out joint inspections for good manufacturing practices (GMPs) as early as
 GaBi Online1 day ago EMA committee recommends marketing approval for Merck Sharp's Zinplava for prevention of recurrence of CDI  PharmaBiz1 week ago Intercept's liver drug gets conditional backing of EMA panel  Reuters1 month ago EMA committee conditionally approves AbbVie leukemia drug  Reuters1 month ago

Marisa Delbò elected as new chair of EMA's committee on HMPC

Marisa Delbò, head of the Risk Management Office at the Italian Medicines Agency (AIFA), was elected as the new chair of the European Medicines Agency's (EMA) Committee on Herbal Medicinal Products (HMPC) at its November meeting. Maria Delbò was ...
 PharmaBiz5 days ago News and press releases: Kaisa Immonen elected as new co-chair of Patients and Consumers Working Party  European Medicines Agency2 days ago
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